150129 apec clark spocs

APEC LSIF training program on Medical Products Integrity and Supply Chain Security:

Establishment of global SPOC Systems

29 January 2015

François-Xavier Lery, EDQM/Council of Europe

Practical tools and approaches for SPOCs

François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.

Content

1. Practicalities: appointment, nomination

2. Information sharing between SPOCs

3. Risk communication


Practicalities of establishment of SPOC network

• Competent authorities (1 State): identification & nomination of SPOCs; 1 National SPOC

• Network (directory of contact details SPOCs): administration & maintenance, confidentiality, updates

• Support tools (SPOC):

• Form/data base information exchange among SPOCs/ periodical reports

• health risk evaluation procedure (suspect product)

• risk communication procedure – awareness campaigns or about a concrete case


Context for SPOC appointment


…Combatting organised crimes requires:

• appropriate powers • responsibility (data confidentiality) • security of SPOCs (national /regional network) • availability: 24/7/365 • access to information/ data (analyses, data bases systematic collection, exchange, sharing of information)

Major role in reduction of health risks; involvement in investigation & judicial procedures

SPOC Nomination

• By Ministries or Heads of Directorates or Agencies:

• Fields:

• Regulation for Pharmaceuticals • Official Medicines Control Laboratories • Police/ Gendarmerie • Customs

(officials only) Note: Industry = reference /contact for support upon request from authorities (case by case)

• Nomination Letter: to be issued by senior official • SPOC & deputy SPOC (1 per competent authority) • 1 National SPOC (international cooperation; link with

national network of SPOC authorities)


Profile of Nominees

• Depends on job duties/functions of post held (officials involved in investigations; operational management of cases of crimes affecting medical products)

• Professional experience

• Contact details of deputy needed

• Agreement to share SPOCs contact details with other SPOC nominees

• Nomination letter duly signed (original) by Director / Head of Agency

• Validity period (unlimited or limited or linked to post) of nomination


Nomination

• Should authorise to make information available within national

network of SPOCs (administrative procedure)

• SPOCs should be warned about risks and consequences of

non-authorised use of information that should stay within the

SPOCs network, or negligent handling of information shared

through the network


Content





Receiving & signal handling/collecting information through SPOCs network

1. Signals: handling – see SPOCs toolkit

2. Rapid Alert : suspect medical product Form PIC/S (Pharmaceutical Inspection Convention Pharmaceutical Inspection Cooperation Scheme) Health risk evaluation Communication (professionals / public)

3. Closed cases: Periodic trend analyses (data/signals, reports, results of preventive /coercive measures) - databases e.g. EDQM’s KnowX or other international organisations

4. Feed-back


Receiving & signal handling/collecting information through SPOCs (network)

Rapid Alert : suspect medical product Example: form PIC/S (Pharmaceutical Inspection Convention Pharmaceutical Inspection Cooperation Scheme)


Receiving & signal handling/collecting information through SPOC network

Closed case (no Rapid Alert): Periodic trend analyses (data/signals, reports, results of preventive /coercive measures) - databases e.g. EDQM’s KnowX or other international organisations

• Medical product description (genuine) – suspect or confirmed falsified (counterfeit)

• Licence holder/Producer/Importer • Modus operandi (criminal activity/alteration) • Distribution path (country of origin-transit-destination) • Conditions of seizure • Signal of harm (suspected/confirmed) • Laboratory results (EDQM/OMCL Network: > 1600 test reports)


SPOC to liaise with Official Medicines Control or Reference Laboratories for analytical testing

In Europe, coordinated by EDQM/Council of Europe

SPOC health authorities: evaluation and risk communication

SPOC customs authorities: circumstances of seizure, distribution path…

SPOC police/gendarmerie authorities: modus operandi, criminal organisation, investigation

(Industry contact: support for risk management)

Analyse of closed case by SPOCs:


Content





Risk communication should be based on risk evaluation

• On-going work of Committee of Experts on Minimising public health risks posed by counterfeit medical products & similar crimes (expert & policy-making levels): CD-P-PH/CMED (EDQM secretariat)

• Procedure for health risk evaluation (suspect product )

• Procedure for risk communication

(courtesy of Ruth Mosimann / Sabine Thomas – Swissmedic)


Approach to evaluation of suspect products

• If possible comparison with reference packaging materials

• In any case look up at :

• Dosage form

• Primary and secondary packaging (appearance, print quality, colour, typographical errors…)

• logo (falsified logos with graphical differences)

• Product leaflet insert (eg paper sheet frequently too thick);

• Safety features (eg seal)

• expiry date

• lot number (primary and secondary packaging)



Example of factors to be taken into account

• Population of patients

• children, elderly patients, large population (antibiotics, painkillers, creams...)

• Indications

• chronic diseases (hypertension, diabetes...)

• Route of administration

• subcutaneous, oral, injectable…



Example of factors to be taken into account

Side effects

• Severity: death or terminal illness, disease duration> 2 weeks, mild and reversible adverse reactions

Category of medical product

eg therapeutic index

Origin of the medical product known?



Goal = rating the health risk

e.g. risk mild / moderate / severe

Guidance for SPOCs for how to handle similar cases reoccuring


Risk evaluation should allow sound risk communication

Reactive communication ( upon concrete case) and proactive communication (awareness of risk/ risk reducing behaviours): fundamentally different approaches & target audience

What is needed for both types of communication:

• establish procedures

• have a strategy based on hard facts

• define what to communicate and to whom


Thank you for your attention

European Directorate

for the Quality of Medicines

& HealthCare (EDQM)


150129 apec clark spocs

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